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发表于 2018-5-29 12:31:01
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本帖最后由 beiwei5du 于 2018-5-29 12:35 编辑
field alert report:
Not surprisingly, foreign holders of NDAs or ANDAs must follow these FARs requirements as well, however, the foreign application holders’ U.S. agents are responsible for reporting the FARs to FDA, and the foreign agent is required to submit the FARs to the district office where they are located. What is interesting, and indeed somewhat suspect, is the statement in the CPG that drugs “distributed in foreign markets” must also follow these requirements. It is unclear what statutory authority FDA would cite for requiring firms with drugs distributed in foreign markets to file field alerts, since these products, by definition, are not under an NDA/ANDA.
Indeed, when reviewing firm SOPs during an inspection, the investigators are to note the firm’s handling and reporting of NDA FARs to ensure their compliance with FDA regulations. The failure of a firm to submit a FAR for a distributed and violative product is reportable as an FDA-483 observation.
The CPG further recommends that significant violations related to a FAR, as well as under-reporting or lack of FAR reporting, should be included in recommendations for advisory actions (i.e., the issuance of an untitled or warning letter, among other possibilities).
Therefore, this serves as a reminder to firms that even when you have closed out your FARs with the district, and even if you have not received any comments or concerns regarding your filing, FDA investigators will be reviewing the firms’ internal documents to all FARs on the subsequent inspection. Forewarned is forearmed, as the proverb goes.
选自：Drug Field Alert Reports – A Brief Overview
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发表于 2018-5-29 11:58:40
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